Accurate SARS-CoV-2 results in 30 minutes

SARS-CoV-2 testing can seem like a choice between accuracy and rapid turnaround time. The rapid Accula SARS-CoV-2 Test uses proprietary Oscar™ PCR technology to shorten thermocycling times and provide a result in 30 minutes. The Limit of Detection (LoD) is among the lowest measured for the FDA SARS-CoV-2 Reference Panel.


Features

The Accula SARS-CoV-2 Test combines the accuracy of PCR with the speed and simplicity of rapid antigen tests, delivering visual results in 30 minutes. The system delivers rapid, accurate, PCR testing with these features:

Accuracy and sensitivity
Comparable to or better than standard lab-based PCR

 

Self-contained

Fully integrated single-use cassette and reusable dock

 
Simple workflow
One minute of hands-on time

Fast turnaround
Proprietary Oscar technology shortens PCR cycling times, providing results in about 30 minutes

 

Authorized for CLIA-waived environments
Available under FDA Emergency Use Authorization (EUA) in settings operating minimally under a CLIA Certificate of Waiver


Accuracy and sensitivity

Test accuracy is measured by percentage agreement with a reference method. In a prospective clinical validation study, the Accula SARS-CoV-2 Test achieved 100% positive and negative percent agreement (PPA and NPA) with an EUA-authorized RT-PCR SARS-CoV-2 test. In other words, every subject who tested positive according to the comparator test also tested positive according to the Accula SARS-CoV-2 Test, and the same for subjects who tested negative.

Concordance with comparator test in prospective clinical study

Accula SARS-CoV-2 Test

Comparator test

Positive

Negative

Total

Positive

4

0

4

Negative

0

48

48

Total

4

48

52

Positive percent agreement (PPA)

100% (95% CI: 39.76%–100%)

Negative percent agreement (NPA)

100% (95% CI: 92.60%–100%)

Overall percent agreement (OPA)

100% (95% CI: 93.15%–100%)

Nasal swab samples were collected from 52 pediatric patients at a drive-through collection site. Testing was performed with the Accula SARS-CoV2 Test and the comparator method, an EUA-authorized RT-PCR SARS-CoV-2 test.

Test sensitivity is measured by limit of detection (LoD) using a reference panel. The lower the limit of detection, the smaller the amount of viral RNA the assay can detect. The FDA established a Reference Panel for SARS-CoV-2 nucleic acid amplification tests (NAATs), enabling direct comparison of LoD across Emergency Use Authorization (EUA) tests, utilizing standardized material and a common protocol. Data reported by the FDA on a variety of NAATs showed that the LoD of the Accula SARS-CoV-2 Test is comparable to the best lab-based RT-PCR test and far more sensitive than all other rapid methods tested.

FDA Reference Panel sensitivity results for widely utilized lab-based and rapid NAATs*

Test type

Limit of detection (NDU/mL**)

Molecular test

Developer

Type of NAAT

Lab-based NAAT

600

Panther Fusion SARS-CoV-2 Assay

Hologic

 RT-PCR

1,800

cobas SARS-CoV-2 assay

Roche Molecular Systems

 RT-PCR

1,800

Quest SARS-CoV-2 assay

Quest Diagnostics

  RT-PCR

2,700

Abbott RealTime SARS-CoV-2 assay

Abbott Molecular

  RT-PCR

Rapid NAAT

475

Accula SARS-CoV-2 Test***

Mesa Biotech (now Thermo Fisher Scientific)

  RT-PCR

5,400

Xpress Xpert SARS-CoV-2 test

Cepheid

  RT-PCR

54,000

Visby Medical COVID-19

Visby Medical

  RT-PCR

60,000****

Cue COVID-19 test

Cue Health

RT-isothermal 

300,000****

ID NOW COVID-19 test

Abbott Diagnostics Scarborough

RT-isothermal

* NAAT = nucleic acid amplification test

** NDU = NAAT/detectable units; an FDA-defined measure of the amount of viral material in a sample. NDU/mL is the metric used by the FDA to allow for a more precise comparison of the analytical performance of different molecular in vitro diagnostic (IVD) assays intended to detect SARS-CoV-2.

*** Accula SARS-CoV-2 Instructions for Use

**** Evaluated using dry swab protocol

Data source: US FDA. SARS-CoV-2 Reference Panel comparative data. Content current as of 12/07/20. Full text


Fast turnaround

Standard lab-based qPCR relies on specialized materials and instruments, highly trained personnel, and transportation of specimens to a centralized laboratory. Samples are batched (many are run at the same time on a high-throughput instrument), and time-to-results can vary from several hours to several days.

 

The Accula SARS-CoV-2 Test accelerates PCR virus detection using our proprietary Oscillating Amplification Reaction (Oscar) PCR technology that enables shortened thermocycling times and faster PCR completion without the need for costly thermal cycler hardware and optical detection systems used in laboratory-based qPCR. Because the test can be administered, run, and interpreted in one place, time-to-results is reduced to 30 minutes—often while the subject waits. This makes the Accula System a practical tool for screening people prior to medical procedures, travel, or at the entrance to a concert or sporting event.

Oscar technology shortens cycling times

Oscillating Amplification Reaction (Oscar), our proprietary PCR technology, enables rapid exponential amplification while reducing overall thermocycling times. Oscar technology completes more cycles than standard PCR in the same amount of time without reducing accuracy or sensitivity.


Self contained

The Accula System consists of the Accula Dock and Accula Test Cassettes. The dock is a small, reusable device about the size of your palm that holds a cassette. It plugs into a standard electrical outlet and provides power to the cassette, which contains the components and reagents for viral lysis, reverse transcription, and PCR amplification. These steps all take place inside the closed cassette under controlled, varying temperatures for optimal results.

The Accula Dock, SARS-CoV-2 Test cassette, transfer pipette and buffer tube sitting on a table in a laboratory environment. The Accula System

When complete, results are visualized on the cassette face as a blue test and/or control line, similar to a home pregnancy test. Each cassette performs a single patient test and is then discarded as biowaste.

 

Tip: Information about other tests using the Accula System platform is coming soon! Assays for Influenza A/B, Respiratory Syncytial Virus (RSV), and Strep A have already received Section 510(k) clearance and CLIA waiver from the FDA.


Authorized for CLIA-waived environments

The Accula SARS-CoV-2 Test has been authorized for emergency use by the US Food and Drug Administration (FDA). It can be used by facilities that minimally have a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver, which is available to clinical laboratories that perform only CLIA-waived tests. “Clinical laboratory” is a broad term that includes hospitals and clinics, but also ambulances, mobile laboratories, and health education fairs.

 

The Accula SARS-CoV-2 Test is used in health care settings to isolate or defer treatments for patients who are in labor, require preoperative assessment, or who receive chemotherapy. In non-healthcare settings, temporary clinical laboratories have been set up close to where testing is required, such as gymnasiums, workplaces, parking lots, and even trailers. The test is excellent for screening individuals going to work or school, or participating in activities involving close human contact such as sports. It can be used in other mobile settings that need to perform frequent, accurate, rapid SARs-CoV-2 testing.

 

Currently, the Accula SARS-CoV-2 Test is authorized for use only in the United States. We are actively pursuing additional registrations.


Simple workflow

The Accula System workflow is elegantly simple: swab, elute, and follow the prompts on the dock to load the sample and run the test. Hands-on time is 1 minute, after which you can walk away. The dock notifies you to read the results when the test is complete.

Simple-workflow

The Accula SARS-CoV-2 Test uses a nasal swab or nasal mid-turbinate swab sample. The test allows for self-collection and elution of a nasal swab sample, minimizing the potential for transmission between subject and tester.

 

Results appear in 30 minutes in an easy-to-interpret lateral flow readout on the cassette face (circled in red in the illustration), much like a home pregnancy test. Any shade of blue at the T (test) position is interpreted as a positive result. Lacking blue at the T position, any shade of blue at the C (positive control) position is interpreted as a negative result. Finally, any shade of blue at the NC (negative control) position, or no blue anywhere, represents an inconclusive or invalid result and should be repeated.

 

Reagents are stored at room temperature (15°C–30°C, 59°F–86°F). Eluted samples in Accula buffer may be kept at room temperature for up to 2 hours, or refrigerated at 2°C–8°C and tested within 24 hours from the time of elution. Eluted samples may also be frozen for longer storage.


Specifications

Accula SARS-CoV-2 Test

Format

Test Cassette Kit

Organism group

Virus

Detectable analytes

SARS-CoV-2 RNA

Sample type

Nasal swab; nasal mid-turbinate swab

Technology

RT-PCR

Control sets

High/low/neg

Shelf life

6 months from date of manufacture

Storage requirements

Room temperature

Regulatory

Certifications/ compliance

FDA Emergency Use Authorized

CLIA complexity

Waived

Accula Dock

Analysis time

~30 minutes

Throughput

~2 tests/hour per dock

Components

Accula Dock, AC power adapter, AC power cord

Electrical requirements

Dock power input: 12VDC ± 1VDC, 1A maximum

AC Power Adapter Input: 100-240VAC, 50/60Hz

AC Power Adapter Output: 12VDC, 2.08A, 25W maximum

Operating temperature

15°C to 30°C (59 to 86°F)

Dimensions (D x W x H)

14.5 x 9.9 x 9.7 cm (5.7 x 3.9 x 3.8 in)

Weight

619 g (<1.4 lb), including Dock, power adapter, and US power cord


Resources and support

Ordering information


This test has not been FDA cleared or approved but has been authorized for emergency use by the FDA for use by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived complexity tests. The test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

 

For Emergency Use Authorization (EUA) Only. For prescription use only. For in vitro diagnostic use.